MedTech Manufacturing worked example

Nonconformance Cost with affected units of 190 devices: a worked example in medtech manufacturing

What does the result look like when affected units reaches 190 devices? The full calculation is worked below with real intermediate numbers. Use this when sizing the financial impact of a nonconformance for MRB review, justifying preventive investments, or trending cost-of-quality metrics.

The inputs for this scenario

  • Affected units: 190 devices (raised for this scenario; the documented default is 75)
  • Material and rework cost per unit: 12 $ / device (unchanged)
  • Fixed investigation cost: 3,500 $ (unchanged)
  • Production disruption cost: 1,800 $ (unchanged)

Working through the calculation

  • Applying the documented formula (Total nonconformance cost = affected units × rework cost per unit + fixed investigation cost + production disruption cost) to the inputs above produces each figure below.
  • At this operating point the engine returns 7,580 $ for total nonconformance event cost, the number this scenario is built around.
  • At this operating point the engine returns 39.89 $ / piece for cost per affected device.
  • At this operating point the engine returns 2,280 $ for total rework/material cost.
  • At this operating point the engine returns 5,300 $ for investigation plus disruption cost.

How this compares with the baseline

  • Against the tool's baseline example, where affected units sits at 75 devices and the headline result is 6,200 $, this scenario comes in 22.26% above the baseline at 7,580 $.
  • A figure at this level is achievable when affected units is genuinely sustained, not just peaked for a shift. It assumes one rework cost per affected unit; if some units are scrapped and others reworked, blend or split the events to avoid a misleading average.

Results at a glance

  • Total nonconformance event cost: 7,580 $ (headline result)
  • Cost per affected device: 39.89 $ / piece
  • Total rework/material cost: 2,280 $
  • Investigation plus disruption cost: 5,300 $

Run it with your numbers

  • Every input above is editable in the live Nonconformance Cost calculator, which recalculates instantly and can be shared with the inputs intact.

Last reviewed 2026-05-12.